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Takahashi, K; Serruys, PW; Chichareon, P; Chang, CC; Tomaniak, M; Modolo, R; Kogame, N; Magro, M; Chowdhary, S; Eitel, I; Zweiker, R; Ong, P; Ottesen, MM; Tijssen, JGP; Wykrzykowska, JJ; de Winter, RJ; Garg, S; Stoll, HP; Hamm, C; Steg, PG; Onuma, Y; Valgimigli, M; Vranckx, P; Carrie, D; Windecker, S.
Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI
J AM COLL CARDIOL. 2019; 74(16): 2015-2027.
Doi: 10.1016/j.jacc.2019.08.997
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Zweiker Robert
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- Abstract:
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Data on optimal antiplatelet treatment regimens in patients who undergo multivessel percutaneous coronary intervention (PCI) are sparse.
This post hoc study investigated the impact of an experimental strategy (1-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus a reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) according to multivessel PCI.
The GLOBAL LEADERS trial is a prospective, multicenter, open-label, randomized controlled trial, allocating all-comer patients in a 1:1 ratio to either the experimental strategy or the reference regimen. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was Bleeding Academic Research Consortium type 3 or 5 bleeding.
Among the overall study population (n=15,845), 3,576 patients (22.4%) having multivessel PCI experienced a significantly higher risk of ischemic and bleeding events at 2 years, compared to those having single-vessel PCI. There was an interaction between the experimental strategy and multivessel PCI on the primary endpoint (hazard ratio: 0.62; 95% confidence interval: 0.44 to 0.88; pinteraction = 0.031). This difference was largely driven by a lower risk of all-cause mortality. In contrast, the risk of Bleeding Academic Research Consortium type 3 or 5 bleeding was statistically similar between the 2 regimens (hazard ratio: 0.92; 95% confidence interval: 0.61 to 1.39; pinteraction = 0.754).
Long-term ticagrelor monotherapy following 1-month DAPT can favorably balance ischemic and bleeding risks in patients with multivessel PCI. These findings should be interpreted as hypothesis-generating and need to be replicated in future dedicated randomized trials. (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation; NCT01813435).
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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drug-eluting stent
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dual antiplatelet therapy
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multivessel percutaneous coronary intervention
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ticagrelor monotherapy